21 CFR Part 58 - Good Laboratory Practice (GLP)
Test Articles and Protocol (Subparts F & G)

21 CFR Part 58 - Good Laboratory Practice (GLP) 58.105: Test and Control Article Characterization

Identity, strength, purity, and composition or other characteristics to define test and control articles must be determined for each batch and documented. Stability must be determined before initiation or concomitantly.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 2 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 211.122 Materials Examination and Usage Criteria
  • 211.84 Testing and Approval of Components

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Test Articles and Protocol (Subparts F & G)

Query this from an agent

The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.